GUEST CONTRIBUTORS

  • Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline
    Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline

    Starting on Nov. 27, 2017, pharmaceutical manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code (product identifier), as stipulated by the Drug Supply Chain Security Act. Many drug makers have been preparing for this so-called “serialization” deadline for years by implementing new processes and systems in their internal operations, or by ensuring efficient transfer of serialization data from their contract manufacturing/packaging partners. However, some manufacturers — in particular, smaller or virtual firms — are now engaged in a mad scramble to meet all the requirements of the deadline.

  • Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation
    Pinpointing Supply Chain Risk Through Line-Of-Sight Shipping Validation

    Shipping and its validation are too often underappreciated in pharmaceutical quality systems (PQS), which can hide risk and uncertainty in the supply chain. A line-of-sight (LOS) approach to shipping validation brings focus to risks in transportation, and rouses quality improvement opportunities throughout the PQS. An LOS approach begins with the end in mind — connecting product critical quality attributes (CQAs) to integrity of the cold chain and to shipping validation design.

  • Is Blow-Fill-Seal Right For Your Aseptic Filling Operation?
    Is Blow-Fill-Seal Right For Your Aseptic Filling Operation?

    United Therapeutics discusses how it uses BFS in its production, the biggest barriers to further industry adoption of the technology, and how recent guidance documents — and a new PDA Technical Report — are helping pharma companies better address challenges and reap the benefits of BFS in their operations.

More From Guest Contributors

PHARMA OUTSOURCING WHITE PAPERS

Accelerate Flavivirus Vaccine Production With Modern Tools And Solutions Accelerate Flavivirus Vaccine Production With Modern Tools And Solutions

Flavivirus vaccine development and production constitute many challenges and can be both space- and resource-consuming. This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production. Single-use production bioreactors and chromatography purification columns mitigate cross-contamination risk and support increased operator safety, while reducing time to market by eliminating costly and time-consuming cleaning operations.

Managing Risk In Biomanufacturing Managing Risk In Biomanufacturing

Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

The Future of BioManufacturing

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.

The Role Of Pharmaceutical Packaging Partners In Times Of Growth

The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont

Customizing The Cold Chain

With things “heating up” in terms of more diverse temperature demands, the industry is moving away from the term cold chain, and we’ll start to see more references to the more inclusive temperature-controlled transport.

Four Reasons For The Rise In Blister Packaging

Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.

More From OP White Papers - random

PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Sharing Instruments: Bottleneck Or Increasing Utilization?

Development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments.

Driving Productivity In Protein Purification

Crucial to the successful operation of any research laboratory is the ability to efficiently generate purified proteins for further investigation and analysis. By Per Lidén (GE Healthcare Life Sciences), Svend Kjær (Cancer Research UK) and Mark Cooper (Abcam)

How A Big Pharma Company Quickly Transferred 2 Oral Powder Antibiotics To Another Facility

Patheon’s Puerto Rico Operations specialize in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.

Vertex Pharmaceuticals: Document Management Strategies For R&D

Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Louis Garguilo Articles

CONNECT WITH US


@OUTSOURCEDPHARM

INDUSTRY INSIGHTS

  •  Quality Metrics: How To Add Value And Meet The FDA’s Expectations
    Quality Metrics: How To Add Value And Meet The FDA’s Expectations

    Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. However, the task of selecting the right metrics to incorporate has always been a bit of a challenge as quality can be subjective and hard to measure in a meaningful way. 

  • CDMOs — At The Core Of Next-Generation Pharma Models
    CDMOs — At The Core Of Next-Generation Pharma Models

    In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.

     

  • Digitally Transforming Laboratory Operations
    Digitally Transforming Laboratory Operations

    “Digital transformation” is a common buzzword across industries today, but is it more than just jargon?  Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.

  • Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off
    Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off

    With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.

  • Can The Cloud Prevent Collaboration Failure In Biopharma?
    Can The Cloud Prevent Collaboration Failure In Biopharma?

    Working in a cloud-based information management and collaboration workspace provides a level of business agility and security that is not available with server-based, on-premises infrastructure. 

More Industry Insights

OUTSOURCING EVENTS

FDA GMP Inspections – Proven Preparation & Survival Techniques June 27, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
How To Establish The Number of Runs Required For Process Validation June 28, 2017
1:00 - 2:00 PM EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum July 10, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
CRO Oversight Post ICH GCP E6 (R2) Addendum July 10, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Conducting an Effective GCP Audit of a CRO-Managed Ongoing Study: Tips and Suggestions July 11, 2017
1:00 - 2:30 PM EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events